Definitions

Common Rule refers to three (3) components that are utilized in reviewing research projects:  Assurance, IRB, and informed consent.

Research means a systematic investigation, including research development, testing and evaluation, designed to develop or contribute to generalizable knowledge. Activities which meet this definition constitute research for purposes of this policy, whether or not they are conducted or supported under a program which is considered research for other purposes. For example, some demonstration and service programs may include research activities.

Human subject means a living individual about whom an investigator (whether professional or student) conducting research obtains:

1. Data through intervention or interaction with the individual, or
2. Identifiable private information.

Intervention includes both physical procedures by which data are gathered (for example, venipuncture) and manipulations of the subject or the subject's environment that are performed for research purposes. Interaction includes communication or interpersonal contact between investigator and subject. Private information includes information about behavior that occurs in a context in which an individual can reasonably expect that no observation or recording is taking place, and information which has been provided for specific purposes by an individual and which the individual can reasonably expect will not be made public (for example, a medical record). Private information must be individually identifiable (i.e., the identity of the subject is or may readily be ascertained by the investigator or associated with the information) in order for obtaining the information to constitute research involving human subjects.

IRB means an institutional review board established in accord with and for the purposes expressed in this policy.

IRB approval means the determination of the IRB that the research has been reviewed and may be conducted at an institution within the constraints set forth by the IRB and by other institutional and federal requirements.

Minimal risk means that the probability and magnitude of harm or discomfort anticipated in the research are not greater in and of themselves than those ordinarily encountered in daily life or during the performance of routine physical or psychological examinations or tests.

Health Insurance Portability and Accountability Act of 1996 (“HIPAA”).  The Privacy Rule standards address the use and disclosure of individuals’ health information—called “protected health information” by organizations subject to the Privacy Rule — called “covered entities,” as well as standards for individuals' privacy rights to understand and control how their health information is used.

Assurance is a document negotiated between an institution and the Department of Health and Human Services (HHS) in accordance with HHS regulations. For research involving human subjects conducted by HHS or supported in whole or in part by HHS, the HHS regulations require a written assurance from the performance-site institution that the institution will comply with the HHS protection of human subjects regulations [45 CFR part 46]. The assurance mechanism is described in 45 CFR 46.103. Once an institution's assurance has been approved by HHS, a number is assigned to the assurance.

Serious Adverse Event is any undesirable experience associated with the use of a medical product in a patient. The event is SERIOUS and should be reported when the patient outcome is:  death, life-threatening, hospitalization (initial or prolonged), disability, congenital anomaly, and requires intervention to prevent permanent impairment or damage.